[Federal Register Volume 64, Number 116 (Thursday, June 17, 1999)]
[Rules and Regulations]
[Pages 32404-32408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15292]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 99N-1502]
Quality Mammography Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations governing mammography. The amendments are intended to
incorporate changes required by the Mammography Quality Standards
Reauthorization Act (MQSRA). Elsewhere in this issue of the Federal
Register, FDA is publishing a companion proposed rule under FDA's usual
procedures for notice and comment to provide a procedural framework to
finalize the rule in the event that the agency withdraws the direct
final rule.
DATES: This regulation is effective November 1, 1999. Submit written
comments on or before August 31, 1999. If FDA receives no significant
adverse comments within the specified comment period, the agency
intends to publish a document confirming the effective date of the
final rule in the Federal Register within 30 days after the comment
period on this direct final rule ends. If timely significant adverse
comments are received, the agency will publish a document in the
Federal Register withdrawing this direct final rule before its
effective date.
Addresses: Submit written comments on the direct final rule to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Roger L. Burkhart, Center for Devices
and Radiological Health (HFZ-240), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20857, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. Background
The Mammography Quality Standards Act (Pub. L. 102-539) (the MQSA)
was passed on October 27, 1992, to establish national quality standards
for mammography. The MQSA required that, to lawfully provide
mammography services after October 1, 1994, all facilities, except
facilities of the Department of Veterans Affairs, shall be accredited
by an approved accreditation body and certified by the Secretary of
Health and Human Services (the Secretary). To become accredited and
certified, a facility had to meet national quality standards to be
established by the Secretary. The authority to establish these
standards, to approve accreditation bodies, and to certify facilities
was delegated by the Secretary to FDA.
Facilities were initially accredited and certified if they met the
standards contained within the interim rules issued by FDA in the
Federal Register of December 21, 1993 (58 FR 67558 and 67565), and
amended by another interim rule published in the Federal Register on
September 30, 1994 (59 FR 49808). More comprehensive standards were
proposed by FDA in the Federal Register of April 3, 1996 (61 FR 14856,
61 FR 14870, 61 FR 14884, 61 FR 14898, and 61 FR 14908). After some
revision in response to the approximately 8,000 comments received on
the proposed rule, a final rule amending part 900 (21 CFR part 900) was
published in the Federal Register of October 28, 1997 (62 FR 55852)
(hereinafter referred to as the October 1997 final rule). The effective
date of most of the new standards contained within the final rule is
April 28, 1999, but a few will not become effective until October 28,
2002.
On October 9, 1998, the MQSRA (Pub. L. 105-248) became law. The
basic purpose of the MQSRA was to extend the authorities established by
the MQSA until September 30, 2002. However, the MQSRA also contained a
requirement that was significantly different from the corresponding
requirement in the October 1997 final rule (62 FR 55852). Although this
MQSRA requirement will become effective on April 28, 1999, with or
without the amendment of the final rule, FDA decided to amend the final
rule to incorporate the change. The purpose of this amendment is to
provide to the mammography facilities the convenience of being able to
find all of the quality standards within a single document instead of
having to consult both the October 1997 final rule and the MQSRA and to
avoid confusion as to the applicable reporting requirement.
Other provisions of the MQSRA clarify the basis for some of the
requirements contained within the October 1997 final rule. FDA is also
amending the final rule to conform its wording of those requirements to
that of the statute.
II. Changes in the Regulations
A. Reporting Requirements
Section 900.12(c)(2) (21 CFR 900.12(c)(2)) of the Ocotober 1997
final rule describes the requirements for communicating mammography
results to the patients. As published in the October 1997 final rule,
these requirements mandated that each mammography facility have a
system to ensure that the results of each examination are communicated
to the patient in a timely manner. Patients without a referring health
care provider were to be sent the report of the examination (as
described in Sec. 900.12(c)(1)) directly by the mammography facility,
along with a written notification or summary of the results in lay
terms. It was further required by the October 1997 final rule that such
self-referred patients should be referred to a health care provider
when clinically indicated.
In the case of patients with a referring health care provider,
Sec. 900.12(c)(3) required that the health care provider receive the
report of the examination. The facility's system for ensuring that
results reached the patient could utilize the services of that health
care provider to achieve that goal. There was no specific requirement
that a summary in lay terms be provided to the patient with a referring
health care provider.
The MQSRA amended the MQSA to specifically require that all
patients, not just self-referred patients, receive directly from the
mammography facility, a summary of the written report in terms easily
understood by a lay person. As previously noted, this MQSRA requirement
will go into effect on April 28, 1999. FDA is amending
Sec. 900.12(c)(2) to incorporate this new requirement.
[[Page 32405]]
B. Clarifications
The MQSRA at several points clarified the provisions of the MQSA
upon which certain requirements of the interim and final rules were
based. In contrast to the change in the patient reporting requirements,
these clarifications became effective on October 9, 1998, the date on
which the MQSRA became law. FDA is amending the regulations to
similarly clarify the wording of the October 1997 final rule on these
points.
1. Review Physicians
The most important function of the accreditation bodies approved by
FDA is to conduct a quality review of clinical images submitted by
facilities seeking accreditation. This review is the key factor in
determining if the facility should be accredited and then certified. It
has been recognized from the start of the MQSA program that the
physicians used by the accreditation bodies to review the clinical
images submitted by the facilities should meet qualifications beyond
those needed to serve as interpreting physicians in mammography
facilities. All accreditation bodies applying to FDA for approval must
demonstrate that their reviewing physicians have the high
qualifications necessary to perform such reviews before approval is
given.
In section 4, the MQSRA emphasized these points by defining the
physicians reviewing clinical images for the accreditation bodies as
``review physicians.'' In the MQSRA definition, it is further
recognized that the accreditation bodies can establish, with FDA
approval, additional qualifications for these review physicians beyond
the qualifications applicable to inspecting physicians in mammography
facilities.
FDA is adding Sec. 900.2(yy) to incorporate the MQSRA definition of
``review physician'' into the final rule. FDA is further amending
Sec. 900.4 in order to use the term review physician at the appropriate
points. In addition, because this term could be confused with the term
``reviewing interpreting physician,'' presently used in connection with
the requirements for the mammography audit, FDA is changing the term,
``reviewing interpreting physician'' to ``audit interpreting
physician'' in Sec. 900.12(f).
2. Patient Notification
The October 1997 final rule at Sec. 900.12(j) states that if FDA
determines that any activity related to the provision of mammography at
a facility presents a sufficiently serious risk to human health, the
agency may require the facility to notify the patients, their
physicians, and/or the public of actions that may be taken to minimize
this risk. This provision was established to aid FDA in fulfilling its
general responsibility under the MQSA to inform the public about
facilities against which the agency has been required to take action
for failure to meet the quality standards. In section 10(a), the MQSRA
provided a specific statement of the agency's authority to require
patient notification. FDA is amending the wording of Sec. 900.12(j) to
bring it into conformance with the wording of the MQSRA on this point.
III. Rulemaking Action
In the Federal Register of November 21, 1997 (62 FR 62466), FDA
described when and how it will employ direct final rulemaking. FDA
believes that this rule is appropriate for direct final rulemaking
because the rule contains direct incorporations of new statutory
mandates. The rule incorporates amendments to section 354(a), (e), (f),
and (h) of the Public Health Service Act made by the MQSRA. FDA
anticipates no significant adverse comment. Consistent with FDA's
procedures on direct final rulemaking, FDA is publishing, elsewhere in
this issue of the Federal Register, a companion proposed rule that is
identical to the direct final rule. The companion proposed rule
provides a procedural framework within which the rule may be finalized
in the event the direct final rule is withdrawn because of any
significant adverse comment. The comment period for the direct final
rule runs concurrently with the comment period of the companion
proposed rule. Any comments received under the companion proposed rule
will be considered as comments regarding the direct final rule.
FDA is providing a comment period on the direct final rule to end
on August 31, 1999. If the agency receives any significant adverse
comment, FDA intends to withdraw this final rule by publication of a
document in the Federal Register within 30 days after the comment
period ends. A significant adverse comment is defined as a comment that
explains why the rule would be inappropriate, including challenges to
the rule's underlying premise or approach, or would be ineffective or
unacceptable without change. It should be remembered, however, that the
requirements themselves were established by the MQSRA. FDA must
implement these statutory provisions.
In determining whether a significant adverse comment is sufficient
to terminate a direct final rulemaking, FDA will consider whether the
comment raises an issue serious enough to warrant a substantive
response in a notice-and-comment process. Comments that are frivolous,
insubstantial, or outside the scope of the rule will not be considered
a significant adverse comment under this procedure. For example, a
comment recommending a rule change in addition to the rule will not be
considered a significant adverse comment, unless the comment shows how
the rule would be ineffective without the additional change. In
addition, if a significant adverse comment applies to an amendment,
paragraph, or section of this rule and that provision can be severed
from the remainder of the rule, FDA may adopt as final those provisions
of the rule that are not the subject of a significant adverse comment.
If FDA withdraws the direct final rule, all comments received will
be considered under the companion proposed rule in developing a final
rule under the usual notice-and-comment procedures under the
Administrative Procedure Act (5 U.S.C. 552 et seq.). If FDA receives no
significant adverse comment during the specified comment period, FDA
intends to publish a confirmation document in the Federal Register
within 30 days after the comment period ends, confirming the effective
date.
IV. Environmental Impact
The agency has determined under 21 CFR 25.34(c) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Analysis of Impacts
FDA has examined the impacts of these amendments under Executive
Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612),
and under the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Regulatory
Flexibility Act requires agencies to analyze the impact of a rule on
small entities. The Unfunded Mandates Reform Act requires (in section
201) that agencies prepare an assessment of
[[Page 32406]]
anticipated costs and benefits before enacting any rule that may result
in an expenditure in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector of $100 million
(adjusted annually for inflation).
As previously noted, the amendments explained under section II.B of
this document concerning clarifications merely clarifies provisions
already contained within the final rule published on October 28, 1997.
The impacts of the provisions of that final rule were discussed in the
preamble of the final rule (62 FR 55852 at 55961), and are unchanged by
the clarifications. Any economic impact of the present amendments is
related solely to the change in the patient reporting requirement
mandated by the MQSRA. Given the statutory basis for extending the
requirement to all mammography facilities effective April 28, 1999, FDA
did not consider alternatives to implementing the requirement.
In the October 1997 final rule, FDA estimated that there were 9,800
mammography facilities that would be considered small. Moreover, FDA
previously estimated the impact of a requirement for sending a lay
summary of results to all patients during the development of its
proposed rule of April 3, 1996 (61 FR 14856), although that requirement
was removed from the October 1997 final rule in response to public
comments (Ref. 1). FDA believes that these estimates remain accurate.
This earlier estimate concerning the impact of required lay
summaries was based upon the assumption that an adequate lay summary of
results could be provided in the great majority of cases in a brief,
standardized format. Using this assumption, it was estimated that the
compliance cost per examination would be $0.94, including the labor of
the office worker and the cost of postage.
To convert this per examination cost to a national total, it was
necessary to make several other assumptions. Using the best data and
expert opinion available at the time, it was estimated that
approximately 25 million mammography examinations were conducted
annually in this country. Of this, it was estimated that 7.7 percent or
1,925,000 were examinations of self-referred patients. Because
facilities were already required by the MQSA (and by the interim rule)
to provide a lay summary of results to self-referred patients, that
portion of the cost of sending lay summaries had already been included
in the impact estimates made in association with the development of the
interim rule of October 27, 1993.
There remained then approximately 23,075,000 patients for which
this was potentially a new requirement. However, it was further
estimated that 40 percent of the patients were already receiving a lay
summary in some form from the facility at which they received their
examinations. Thus, the new requirement would lead to additional lay
summaries in only 60 percent of the referred examinations or
approximately 13,845,000. At $0.94 a lay summary, the added cost would
be slightly over $13 million a year.
Two major changes have occurred since the information upon which
these estimates were based was collected in late 1995. Most
significantly, through FDA's activities and those of other private and
government groups, public awareness of the need for regular mammography
examinations and public confidence that a high quality examination will
be received have both increased. As a result, the number of
examinations given per year has increased to an estimated 40 million.
This requires increasing the costs estimated above by 60 percent.
Postage rates have also gone up $0.01 per letter thus the cost per lay
summary would increase from $0.94 to $0.95. The combined impact of
these two changes is to increase the estimate of the annual incremental
costs to meet this new requirement to approximately $21 million.
For the great majority of cases, the assumption that the lay
summaries can be provided in brief, standardized format is valid.
However, in approximately 10 percent of the cases, the overall
assessment of the findings is expected to be ``Suspicious'' or ``Highly
suggestive of malignancy.'' In such cases, the facility is required to
``make reasonable attempts to ensure that the results are communicated
to the patients as soon as possible.''
Facilities that accept self-referred patients are already required
by the final rule to make such attempts for cases with an overall
assessment of ``suspicious'' or ``highly suggestive of malignancy.''
Based upon the assumption that the attempt would involve a 5 minute
telephone conversation of the interpreting physician with the patient,
a cost of $8.93 per examination was estimated. This cost would be in
addition to the $0.95 estimated cost for the written lay summary, which
would still need to be sent. Assuming that this would be a new cost for
10 percent of the 60 percent of the referred patients among the 40
million receiving examinations annually, the incremental cost for these
contacts is approximately $21.4 million.
The total annual incremental cost due to this new requirement,
therefore, would be approximately $42.4 million. Previously, the annual
cost for compliance with the interim and final MQSA rules was estimated
at $61.5 million (Ref. 2). Adding the cost of compliance with this new
requirement brings the total annual cost of compliance with the final
rule as amended to approximately $103.9 million.
Compliance with the new requirement would also be expected to
increase the benefits from mammography. Mammography is the most
effective technique presently available for the early detection of
breast cancer. Early detection of breast cancer followed by prompt
treatment can avert mortalities that can result if treatment is delayed
until the cancer reaches a more advanced stage. In addition, the cost
and severity of the treatment methods will in general be less when the
cancer is treated at an early stage. Even in cases where the assessment
is negative, there is expected to be a benefit arising from relieving
the anxiety of the patient about the possible results of the
examination through prompt reporting of results to the patient. But for
these benefits to be gained, the patient must be informed of the
results of the examination so that necessary followup actions can be
promptly taken. Unfortunately, although it is not possible to make a
quantitative estimate of the number of such cases, there have been
frequent complaints about patients receiving the results of their
examinations after an undue delay or not at all. Studies have also
shown that direct communication of results to the patient by the
mammography facility, as compared to traditional communication
procedures where the facility communicates only with the referring
provider, produces an improvement in compliance with followup
recommendations (Ref. 3). The new requirement should thus add to the
benefits expected from interim and final rules, which were previously
estimated to range from $284 to $408 million (61 FR 55986), primarily
due to a gain in averted mortalities (Ref. 2).
Based on these analyses, FDA has determined that the rule is
consistent with the principles set forth in the Executive Order, the
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act. The
wording of the requirement related to sending lay summaries to referred
patients directly parallels that of the MQSRA and so, in accordance
with the Executive Order, maximizes the net benefits to the extent
allowed by that statute. Similarly, in accordance with the Regulatory
[[Page 32407]]
Flexibility Act, the impact of the rule on small entities has been
analyzed. Finally, as noted previously, the incremental annual
expenditures (beyond those already incurred from the previous interim
and final rules) required by the rule are estimated at $42.4 million
and thus do not exceed $100 million in 1 year so the rule does not come
under the requirements of the Unfunded Mandates Reform Act.
VI. Paperwork Reduction Act of 1995
This direct final rule contains information collection provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown below with an estimate of the annual
reporting and recordkeeping burden. Included in the estimate are the
times for reviewing the instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Lay Summary of Examination Results to Patients.
Description: This regulation merely implements a statutory
information collection requirement; there is no additional burden
attributable to the regulation. This direct final rule would conform
the requirements of this section with the requirement of section 6 of
Pub. L. 105-248 states that: ``(IV) whether or not such a physician is
available or there is no such physician, a summary of the written
report shall be sent directly to the patient in terms easily understood
by a lay person.'' To produce the required lay summary, the mammography
facilities will review the medical report of each patient's examination
and collect from it the necessary information.
Respondent Description: Businesses and other for-profit
organizations, nonprofit organizations.
As provided in 5 CFR 1320.5(c)(1), collections of information in a
direct final rule are subject to the procedures set forth in 5 CFR
1320.10. Interested persons and organizations may submit comments on
the information collection provisions of this direct final rule by
August 31, 1999 to the Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
At the close of the 75-day comment period, FDA will review the comments
received, revise the information collection provisions as necessary,
and submit these provisions to OMB for review. FDA will publish a
notice in the Federal Register when the information collection
provisions are submitted to OMB, and an opportunity for public comment
to OMB will be provided at that time. Prior to the effective date of
the direct final rule, FDA will publish a notice in the Federal
Register of OMB's decision to approve, modify, or disapprove the
information collection provisions. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
VII. References
The following references are on display at the Dockets Management
Branch (address above) and may be seen by interested persons between 9
a.m. and 4 p.m., Monday through Friday.
1. Eastern Research Group, ``Cost and Benefit Analysis of
Regulations Under the Mammography Quality Standards Act of 1992-
Preliminary Final,'' March 14, 1996.
2. Eastern Research Group, ``Economic Impact Analysis of
Regulations Under the Mammography Quality Standards Act of 1992-
Final,'' October 7, 1997.
3. Agency for Health Care Policy and Research (AHCPR), ``Quality
Determinants of Mammography,'' AHCPR Pub. No. 95-0632, October 1994.
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 900 is amended as follows:
PART 900--MAMMOGRAPHY
1. The authority citation for part 900 continues to read as
follows:
Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.
2. Section 900.2 is amended by adding paragraph (yy) to read as
follows:
Sec. 900.2 Definitions.
* * * * *
(yy) Review physician means a physician who, by meeting the
requirements set out in Sec. 900.4(c)(5), is qualified to review
clinical images on behalf of the accreditation body.
3. Section 900.4 is amended by revising the last sentence of
paragraph (a)(4); and by revising paragraphs (c)(3)(ii), (c)(5)
introductory text, (c)(5)(i), (c)(5)(ii), and (c)(6)(ii) to read as
follows:
Sec. 900.4 Standards for accreditation bodies.
(a) * * *
(4) * * * Such individuals who review clinical or phantom images
under the provisions of paragraphs (c) and (d) of this section or who
visit facilities under the provisions of paragraph (f) of this section
shall not review clinical or phantom images from or visit a facility
with which such individuals maintain a relationship, or when it would
otherwise be a conflict of interest for them to do so, or when they
have a bias in favor of or against the facility.
* * * * *
(c) * * *
(3) * * *
(ii) All clinical images submitted by a facility to the
accreditation body shall be reviewed independently by two or more
review physicians.
* * * * *
(5) Review physicians. Accreditation bodies shall ensure that all
of their review physicians:
(i) Meet the interpreting physician requirements specified in
Sec. 900.12(a)(1) and meet such additional requirements as have been
established by the accreditation body and approved by FDA;
(ii) Are trained and evaluated in the clinical image review
process, for the types of clinical images to be evaluated by a review
physician, by the accreditation body before designation as review
physicians and periodically thereafter; and
* * * * *
(6) * * *
(ii) If a review physician identifies a suspicious abnormality on
an image submitted for clinical image review, the accreditation body
shall ensure that this information is provided to the facility and that
the clinical images are returned to the facility. Both shall occur no
later than 10-business days after
[[Page 32408]]
identification of the suspected abnormality.
* * * * *
4. Section 900.12 is amended by revising paragraphs (c)(2) and
(f)(3) and the first sentence of paragraph (j)(2) to read as follows:
Sec. 900.12 Quality standards.
* * * * *
(c) * * *
(2) Communication of mammography results to the patients. Each
facility shall send each patient a summary of the mammography report
written in lay terms within 30 days of the mammographic examination. If
assessments are ``Suspicious'' or ``Highly suggestive of malignancy,''
the facility shall make reasonable attempts to ensure that the results
are communicated to the patient as soon as possible.
(i) Patients who do not name a health care provider to receive the
mammography report shall be sent the report described in paragraph
(c)(1) of this section within 30 days, in addition to the written
notification of results in lay terms.
(ii) Each facility that accepts patients who do not have a health
care provider shall maintain a system for referring such patients to a
health care provider when clinically indicated.
* * * * *
(f) * * *
(3) Audit interpreting physician. Each facility shall designate at
least one interpreting physician to review the medical outcomes audit
data at least once every 12 months. This individual shall record the
dates of the audit period(s) and shall be responsible for analyzing
results based on this audit. This individual shall also be responsible
for documenting the results and notifying other interpreting physicians
of their results and the facility aggregate results. If followup
actions are taken, the audit interpreting physician shall also be
responsible for documenting the nature of the followup.
* * * * *
(j) * * *
(2) If FDA determines that the quality of mammography performed by
a facility, whether or not certified under Sec. 900.11, was so
inconsistent with the quality standards established in this section as
to present a significant risk to individual or public health, FDA may
require such facility to notify patients who received mammograms at
such facility, and their referring physicians, of the deficiencies
presenting such risk, the potential harm resulting, appropriate
remedial measures, and such other relevant information as FDA may
require. * * *
Dated: June 9, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-15292 Filed 6-16-99; 8:45 am]
BILLING CODE 4160-01-F
